Harmonizing Optimal Strategy for Treatment of Coronary Artery Stenosis- CloPidogREl for Primary preVENTION (HOST-PREVENTION)
Efficacy and Safety of Clopidogrel for Primary Prevention in Patients With Subclinical Coronary Atherosclerosis Identified on Imaging
Seoul National University Hospital
11,086 participants
Mar 22, 2023
INTERVENTIONAL
Conditions
Summary
The investigators will evaluate the efficacy and safety of clopidogrel for primary prevention in patients diagnosed with coronary atherosclerosis on imaging that did not require revascularization therapy. The trial will test the hypothesis that clopidogrel is beneficial in preventing major adverse cardiovascular and cerebrovascular events (MACCE) in patients with subclinical coronary atherosclerosis identified on imaging.
Eligibility
Inclusion Criteria4
- Male or female aged ≥40 years
- Patients with subclinical coronary atherosclerosis identified from coronary CT angiography or coronary angiography within 2 years without clinical events after an imaging study
- Without significant coronary artery stenosis (Diameter stenosis >50%), which needs revascularization
- Agreement to give written informed consent
Exclusion Criteria9
- A history of a diagnosed cardiovascular or cerebrovascular disease (Type1 myocardial infarction, heart failure, peripheral artery disease, stroke, transient ischemic attack, carotid artery stenosis>50%, carotid artery intervention)
- A history of coronary artery intervention or coronary artery bypass graft surgery, which needs chronic maintenance of antiplatelet therapy
- Absolute contraindication or allergy to clopidogrel
- Patients receiving anticoagulants for other comorbidities
- A history of Bleeding diathesis, known coagulopathy, or major bleeding, BARC class ≥3, resulting in the stop of antiplatelet agents
- Planned surgery or intervention which needs to stop antiplatelet agents ≥1 month
- Presence of non-cardiac comorbidity with life expectancy ≤ 5 years at randomization
- Females with pregnancy or breast-feeding
- Patients who are thought to be inappropriate for the trial based on physicians' decision
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Interventions
Patients assigned to the clopidogrel treatment group will maintain clopidogrel 75mg once a day for at least 5 years.
Patients assigned to the no antiplatelet or anticoagulant group will not prescribe antithrombotics for at least 5 years. However, when there is a medical need for antithrombotic therapy during the follow-up, the prescription of antithrombotics is permitted with reporting to the research board.
Locations(61)
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NCT05845489